During placement of an intravascular catheter, the current standard of care technique includes flushing of the newly inserted catheter with sterile saline solution to clear the hub and catheter of blood that would otherwise coagulate and result in loss of catheter function. Present standard catheter placement and flush methodology involves several separate, often one-handed, sequential steps using non-sterile gloves.
First, the insertion site is prepped with sterilizing solution (e.g., chlorhexidine). Second, using non-sterile gloves, the vascular catheter is inserted through the skin and into the blood vessel, taking care not to touch the actual insertion site or catheter with the non-sterile gloves. Third, with one hand, the insertion needle is withdrawn from the catheter and put aside (e.g., on a bed or side table). During this time, the other hand stabilizes the catheter hub and applies pressure to the blood vessel upstream from the insertion site to prevent back-bleeding. Care must be taken not to touch the insertion site (either the catheter or the surrounding skin) with the non-sterile gloved hand. Fourth, the hand that withdrew the needle then reaches for and obtains from the local area (e.g., bed or side table) an IV hub cap device (e.g., a Luer Lock® connector, a Clave® connector, or extension tubing with attached Clave®), which is placed both to prevent backflow of blood into the catheter and to allow for mechanical connection to, and use of, the catheter. The hub cap device packaging has been pre-opened and set aside within reach to allow one-handed pick up and manipulation of the hub cap during this process.
Fifth, the free hand then reaches for and obtains from the local area (e.g., bed or side table) a syringe that has been pre-filled with sterile saline. Sixth, the syringe is attached to the hub cap device, and the saline solution is injected/flushed into the connection device-catheter complex to displace blood from the catheter into the blood vessel, leaving the catheter filled with saline solution. Seventh, the syringe is detached and put aside. Eighth, and finally, a “sterile” dressing is then placed over the catheter hub and skin insertion site (although often at this point neither the catheter or dressing is sterile, as during the process they have been touched repeatedly by non-sterile gloved fingers). Additional adhesive tape is then applied to further secure and position the catheter.
Wide variations in this process occur, leading consequently to highly-variable results. One common variation is to flush the catheter with saline prior to placing the hub cap device. In other instances, an IV line is attached directly to the hub and IV fluid administration initiated (thereby negating the need for saline flush). In all instances, the technique is awkward, requires the use of multiple complex one-handed maneuvers at multiple time points, and requires use of an often unprepared working area beyond the actual insertion site (e.g., bed or side table)—an area that is usually not sterile/clean.
Looming over this standard vascular catheter insertion process is the desire for sterility and the prevention of outside organisms (e.g., hospital environment bacteria) from reaching the catheter insertion site. While this is the goal, in reality it is extremely difficult to achieve. The complexity of the catheter insertion and flush procedure, combined with the fact that it is done over such a broad and varied working area with non-sterile gloves, leaves multiple points for loss of sterile technique. All too often, the end result of this highly complex and variable process is a non-sterile catheter and catheter insertion site. This lack of sterility is compounded over time by the placement of a non-sealing dressing that cannot maintain sterility even if it is able to be achieved initially. The result is the increased loss of catheters from site infection, and the need to change catheters and dressings at relatively frequent intervals in hopes of preventing clinical expression of catheter infection. One very clear marker of the inadequacy of existing catheter insertion-dressing placement technique is the increasing reliance on compensatory measures such as antimicrobial adjuncts and supplementary securement devices.
Accordingly, a need exists for improved methods and devices for sterile placement and maintenance of catheters.